3 stem cell procedures recognized in PH FDA

The Food and Drug Administration (FDA) yesterday reiterated that stem cell procedures in the Philippines are allowed only for three specific procedures while others remain unrecognized by the agency and are therefore illegal.

In an advisory posted on its website, Dr. Kenneth Hartigan-Go, FDA acting director, emphasized that only the following uses of stem cell therapy are recognized by the FDA Hematopoietic Transplantation (involving the blood cells to treat disorders of the blood and immune systems), Corneal Resurfacing with limbal stem cells (to treat the transparent, front part of the eye), and skin regeneration (for burns) with epidermal stem cells. All hospitals and health facilities are likewise warned that Republic Act 9711 or the FDA Act, otherwise prohibits the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product that is unregistered. The use of Human cells, Tissues, and Cellular and tissue-based products (HCT/Ps) without the authorization or permission by the FDA is considered illegal in the country, Go said.

In August 2013, the FDA issued a circular asking hospitals and other facilities offering stem cell procedures to register for accreditation. However, as of May 2, the FDA said not one stem cell or HCT product that applied for registration has been registered by the FDA for compassionate or clinical trial use or for general use.

What we are doing now is we are strengthening quality assurancethey must have scientific proof. But there is no one who is applying for compassionate use because if we ask them about ethical clearance, they have no ethical review system, the FDA chief added.

Go warned all hospitals and health facilities to stop manufacturing or selling unregistered products.

The warning also covers unlicensed practitioners from other countries and tourists who visit the country for leisure or medical needs. (Jenny F. Manongdo)

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3 stem cell procedures recognized in PH FDA